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Undergraduate Medical Teaching: Time to integrate?
1Dept. of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai.
The Journal of the Association of Physicians of India
|July 21, 2019
Summary
Delamanid is a novel drug effective against drug-resistant tuberculosis by inhibiting mycolic acid synthesis. While approved in several countries, ongoing research is needed for specific patient groups and drug combinations.
Area of Science:
- Pharmacology
- Microbiology
- Infectious Diseases
Background:
- Drug-resistant tuberculosis (TB) poses a significant global health challenge.
- Delamanid, a nitro-dihydro-imidazooxazole, exhibits in-vitro and in-vivo activity against resistant Mycobacterium tuberculosis strains.
- Mycolic acid biosynthesis inhibition is the primary mechanism of action for Delamanid.
Purpose of the Study:
- To review the development, approval status, and clinical use of Delamanid.
- To highlight the efficacy and safety profile of Delamanid in treating drug-resistant TB.
- To identify areas requiring further clinical investigation for Delamanid.
Main Methods:
- Review of preclinical and clinical trial data for Delamanid.
- Analysis of regulatory approval timelines and geographical distribution.
- Assessment of reported adverse events and WHO recommendations.
Main Results:
- Delamanid demonstrated efficacy in Phase 2 trials and received regulatory approval in the EU, Japan, and Korea in 2014, and India in 2017.
- The drug is generally well-tolerated, with QT prolongation being a noted concern.
- The World Health Organization conditionally recommends Delamanid in combination regimens for pulmonary TB.
Conclusions:
- Delamanid represents a valuable therapeutic option for drug-resistant tuberculosis.
- Further clinical data is essential to guide the use of Delamanid in pediatric populations, HIV-coinfected patients, pregnant women, and in combination with Bedaquiline.
- Continued research will refine the optimal application of Delamanid in diverse clinical settings.
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